Daewoong Bio completes Hwaseong biopharm plant to expand global CMO biz for microbial-based drugs
Daewoong Bio said Thursday that it has completed the construction of its bio plant in Hwaseong, Gyeonggi Province. The project began in March last year to expand its mass contract manufacturing organization (CMO) business for microbial-based biopharmaceuticals.
The bio plant was designed to the Good Manufacturing Practice (cGMP) level required by the U.S. Food and Drug Administration (FDA), securing global competitiveness in developing and producing biopharmaceuticals.
Daewoong Bio has installed the latest raw and finished product production equipment, including fermenters, continuous centrifuges, liquid vial fillers, prefilled syringes, and lyophilizers for producing microbial-based recombinant drugs. Daewoong Bio will complete the SAT (site acceptance test) and equipment qualification this year.
The company said it also has put in place measures to enhance the transparency and credibility of the bioreactor. For instance, it has installed a large viewing window so that clients and regulatory inspectors can take a closer look at the production process and manufacturing site.
In addition, it applied a one-way flow system to prevent cross-contamination in the production area, implemented an automation system from raw material receipt to shipment to increase cost competitiveness, and introduced a manufacturing control system (MCS) to maximize the efficiency and accuracy of the manufacturing process.
Besides, Daewoong Bio established independent finished product production lines for various formulations, including liquid vials, freeze-dried cartridges, and spray topical solutions, to flexibly respond to the needs of various customers.
The Daewoong Group has the know-how for certifications, including the U.S. FDA cGMP and the European Medicines Agency (EMA) GMP. In 2018, Daewoong Pharmaceutical's Nabota production plant received cGMP and EU GMP certification. Based on these capabilities, Daewoong Bio hopes to obtain GMP approval from the Ministry of Food and Drug Safety in 2027 and U.S. FDA in 2028.
Daewoong Bio specializes in microbial-based biopharmaceuticals to produce active pharmaceutical ingredients (APIs). For finished pharmaceuticals, the company plans to meet customers' needs flexibly by producing products, including vials, cartridges, and spray (external solution) formulations, such as microorganisms and animal cells.
Daewoong Bio added that it is also preparing to become a specialized contract development and manufacturing organization (CDMO), moving beyond its current role as a CMO for microbial-based gene recombinant drugs.
Unlike CMOs, which only support product production, CDMOs collaborate on the entire process of drug development, including production, clinical, and commercialization, and aim to provide full-cycle services from cell line development to product packaging. Biopharmaceutical production is measured by the capacity of the incubator used in the cell culture process, and Daewoong Bio has secured a production capacity of 1000L, the second largest in Korea.
“We will equip related facilities as planned so that we can flexibly respond to the needs of all our customers, both at home and abroad,” said Pyun Do-kyu, head of Daewoong Bio's production headquarters. “From next year, we will start producing microbial-based biopharmaceuticals and enter the global CMO market to accelerate our efforts to achieve 1 trillion won ($750 million) in sales by 2030.”
Pyun said that from this year, Daewoong Bio will focus on actively participating in domestic and international biotechnology exhibitions to introduce the features of its biopharmaceutical plant to potential customers at home and abroad.
“To start with, we plan to participate in CPHI Milan 2024, a worldwide convention on pharmaceutical ingredients, in Milan, Italy, in October,” he added.